07.05.2020

CMC Expert, Biologicals (m/f/d)

(in Full-time) (unlimited contract)

The Powerhouse for Anti-infectives –
Committed to making the difference

 

AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “block buster” potential to the market (Prevymis® 2017/18).

 

AiCuris is offering the position of a: 

CMC Expert, Biologicals (m/f/d) 

(in full time)


Reporting to the Head of Chemistry, Pharmaceutical Development and Patent Affairs

In this role you will be responsible for the co-ordination of all CMC activities (outsourcing) for all the AiCuris biological development projects.

 

Responsibilities

 
  • To support development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing
  • Conceptualize and lead early and late stage formulation development (liquid, lyophilized, high concentration etc.) for macromolecules (Proteins and antibodies)
  • Develop and optimize processes for drug substance
  • Manage activities relevant to drug product development (mixing studies, filtration studies, extractable/leachable studies etc.)
  • Responsible for technology transfer from the early stage CROs  to late stage CMOs during different phases of product development
  • Actively contribute to relevant part of CTD section 3 of IND/IMPD’s.
  • Interpret and report results of work carried out in written and verbal format performed with  external partners
  • Evaluate external developments in the area of drug substance manufacturing and formulation development

 

Skills and qualification

 
  • PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3-5 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 8 years industrial experience
  • Significant experience in protein/monoclonal antibodies/bispecifics formulation for both early and late phase development
  • Experience in process development related to drug substance and drug products (lyophilization) manufacturing
  • Knowledge of technology transfer and regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing
  • Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment)
  • Ability to manage development and manufacturing with external partners
  • Experience in regulatory relationships (scientific advices)
  • Fluency in English, both written and verbal
  • Excellent communication skills and strong diplomacy skills required

 

What we can offer

 
  • Cooperation in multinational and interdisciplinary teams
  • An exciting and challenging job in a promising research and development company with an excellent R&D portfolio
  • Flexible working hours and self-determined time management
  • Regular and targeted further training and individual development opportunities
  • Attractive company pension scheme
  • A wide range of services relating to health and reconciling work and family life

 

How to apply

You can find a PDF of the job description here. 

Interested to join our team?
Then apply online (click here).
If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.

 

Note for headhunters: We are not interested in support. Thanks!

 

AiCuris Anti-infective Cures AG

Human Resources
Anna Frey
Friedrich-Ebert-Str. 475 / Build. 302
42117 Wuppertal
Germany

www.aicuris.com

 


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